MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE EYE STATION; CAMERA, OPHTHALMIC, AC-POWERED

Model Number MERGE EYE STATION V11.4

Device Problems Operating System Becomes Nonfunctional (2996); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare continues to contact the customer to further investigate the allegation and to determine if additional actions are required.When additional information becomes available a supplemental report will be submitted.

Event Description

Merge eye station is intended to be used in conjunction with existing ophthalmic fundus cameras to take images of the eye, perform fluorescein angiography, red free, color and icg still-image photography as well as video imaging.On 0(b)(6) 2016, merge healthcare was notified, by a customer, that a computer was taking thirty (30) minutes to boot and that the system needed to be rebooted several times a day to become responsive again.The customer also reported that the focus dots in the camera were not showing up.The customer requested that a technician be sent to the account.On (b)(6) 2016, it was determined, by support, that the issue was either related to the power supply or the motherboard.At that time, it was documented that the system was operational.On (b)(6) 2016, follow-up occurred with the customer that indicated that the system was down for several days, resulting in an inability to take images of the eye with the eye station camera.The customer stated that they had corrected the issue, without the help of support.Additional information regarding the resolution was requested from the customer but has not been received.There is no information indicating that this event led to a serious injury or an adverse event for a patient.(b)(4).

• Brand Name: MERGE EYE STATION
• Type of Device: CAMERA, OPHTHALMIC, AC-POWERED
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland, WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge dr.; hartland,, WI 53029 ; 2629123570
• MDR Report Key: 5802761
• MDR Text Key: 49857591
• Report Number: 2183926-2016-00641
• Device Sequence Number: 1
• Product Code: HKI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE EYE STATION V11.4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1